INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo INTRAMED ERGOMETRINE Injection 0,2 mg/mL
INTRAMED ERGOMETRINE Injection 0,5 mg/mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

INTRAMED ERGOMETRINE Injection 0,2 mg/mL
INTRAMED ERGOMETRINE Injection 0,5 mg/mL

COMPOSITION:
Ampoules containing 0,2 or 0,5 mg
ergometrine maleate per 1 mL.

PHARMACOLOGICAL CLASSIFICATION:
A 19 Oxytocics

PHARMACOLOGICAL ACTION:
Ergometrine stimulates smooth muscle, especially that of the uterus, arteries and veins, producing contraction or constriction.

INDICATIONS:
To control bleeding and maintain uterine contraction post-partum and post abortion.

CONTRA-INDICATIONS:
Pregnancy, during the first and second stages of labour; in severe or persistent sepsis, obstetric patients with cardio-vascular disease, chronic anaemia, toxaemia of pregnancy or eclampsia; impaired hepatic, renal or respiratory function. Nursing mothers.

WARNINGS:
Numbness or tingling of the extremities indicates that administration should be discontinued.

DOSAGE AND DIRECTIONS FOR USE:
Treatment of postpartum haemorrhage:
0,2 mg intramuscularly. Repeat within 2 to 4 hours if necessary.
In emergencies 0,2 mg may be given intravenously.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The vasoconstrictor effects of ergometrine are enhanced by sympathomimetic agents such as adrenaline and dopamine. The effect on the parturient uterus are diminished by halothane.
Adverse effects include headache, dizziness, tinnitus, abdominal pain, nausea, vomiting, hypertension, chest pain, palpitation, dyspnoea, bradycardia, diarrhoea, weakness, formication, itching, coldness of the skin, confusion, depression, drowsiness, convulsions, hemiplegia, tabetic manifestations and a fixed miosis.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See side-effects and precautions. Other symptoms include an unquenchable thirst, tingling, a rapid and weak pulse, unconsciousness, arterial pulse in the affected limbs become faint or disappear and eventually gangrene develops.
Treatment is symptomatic and supportive. Withdraw the ergometrine administration and maintain an adequate circulation to prevent gangrene.

IDENTIFICATION:
A clear colourless or faintly yellow solution in amber ampoules.

PRESENTATION:
1 mL ampoules of 0,2 or 0,5 mg in boxes of 10.

STORAGE INSTRUCTIONS:
Protect from light.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
0,2 mg/mL X/19/262
0,5 mg/mL X/19/263

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD
6 Gibaud Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Dec 91   12-129/10-93
    Tradepak P.E.

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